FDA Approves Drug For Short Bowel Syndrome



January 2, 2013

FDA approves drug for short bowel syndrome but with a rider

(Reuters) - U.S. health regulators have approved the drug Gattex made by NPS Pharmaceuticals for short bowel syndrome, but asked the company to conduct a post-market study to evaluate cancer risks associated with the drug.

Short bowel syndrome is a condition in which the body is unable to absorb enough nutrients through the gastrointestinal tract and that forces patients to rely on intravenous feeding. It is mostly caused by the surgical removal of large parts of the small intestine.

Gattex, administered once daily, improves intestinal absorption of fluids and nutrients, and reduces the frequency and volume of intravenous feeding.

An FDA advisory panel in October had unanimously backed Gattex, also called teduglutide, but discussed the possibility that it could cause cancerous tumors in the small intestine when used over a long period.

The post-market study, conducted over 10 years, would test the potential risk of the drug to cause colorectal cancer and other conditions.

Gattex is the third FDA-approved drug to treat adults with short bowel syndrome receiving nutritional support.

The company said it would launch the drug in the United States in the first quarter of next year.

 


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